Oragenics, Inc. (OGEN) is a development-stage biopharmaceutical company dedicated to the research and development of nasal delivery pharmaceutical medications and vaccines. The company's focus has recently shifted to the development of medical products that treat brain-related illnesses and diseases, with its lead product candidate being ONP-002 for the treatment of mild traumatic brain injury (mTBI) or concussion.

Business Overview

Oragenics was incorporated in November 1996 and previously focused on the development of a nasal delivery vaccine candidate to provide long-lasting immunity from SARS-CoV-2, which causes COVID-19. However, in December 2023, the company acquired certain assets from Odyssey Health, Inc. related to the development of medical products that treat brain-related illnesses and diseases. This acquisition has become the company's primary focus, with ONP-002 as the lead product candidate.

ONP-002 for Concussion Treatment

ONP-002 is a proprietary powder formulation that is administered intranasally using a novel, lightweight, and easy-to-use device. The drug candidate has demonstrated stability up to 104 degrees Celsius for 18 months and is designed to rapidly and directly access the brain, leveraging the intranasal delivery mechanism to cross the blood-brain barrier.

Preclinical studies have shown that ONP-002 has a large safety margin and has demonstrated positive behavioral outcomes in animals, including improved memory, sensory-motor performance, and reduced depression/anxiety-like behavior. The drug has also been shown to reduce swelling, inflammation, and oxidative stress in the brain.

Clinical Trials

ONP-002 has completed a successful Phase 1 clinical trial in healthy human subjects, demonstrating that the drug is safe and well-tolerated. The Phase 1 study was a double-blinded, randomized, and placebo-controlled trial using a single ascending/multiple ascending dose (SAD/MAD) design. The trial enrolled 40 subjects (31 males, 9 females) and the Safety Review Board determined that the drug is safe and well-tolerated at all dosing levels.

Oragenics is now preparing to initiate a Phase 2 clinical trial program for ONP-002. The company plans to conduct a Phase 2a feasibility study in Australia, followed by a Phase 2b proof-of-concept study in the United States. The Phase 2 trials will evaluate the safety and efficacy of ONP-002 in concussed patients, with the drug being administered intranasally twice daily for up to 14 days.

Intellectual Property

Oragenics has filed and/or issued several patents related to ONP-002 and the associated nasal delivery device. This includes a new chemical entity patent filing for the C-20 steroid compounds, as well as a patent filing for the breath-powered nasal delivery device.

Financials

For the fiscal year ended December 31, 2023, Oragenics reported annual net income of -$20,655,737, annual revenue of $37,653, annual operating cash flow of -$7,290,880, and annual free cash flow of -$7,290,880. The company's financial performance has been impacted by its ongoing research and development efforts, as well as the costs associated with being a public company.

In the first quarter of 2024, Oragenics reported a net loss of $2,450,833, with research and development expenses of $663,414 and general and administrative expenses of $1,796,689. The company had a working capital surplus of $1,534,515 as of March 31, 2024.

Liquidity and Capital Resources

Oragenics has funded its operations primarily through the sale of equity securities, debt financing, and grants. As of March 31, 2024, the company had cash and cash equivalents of $2,071,989, which it believes will be sufficient to fund its operating plan through the third quarter of 2024.

However, the company has received a notice from the NYSE American that it is no longer in compliance with the exchange's continued listing standards due to its shareholders' equity being below the required minimum. Oragenics is required to submit a plan of compliance by May 18, 2024 to address how it intends to regain compliance by October 18, 2025.

The company's ability to continue its operations and advance the development of ONP-002 is dependent on its ability to raise additional capital through various means, including public or private equity offerings, debt financing, or strategic partnerships. Failure to secure additional funding could significantly impact the company's ability to continue its research and development activities.

Risks and Challenges

Oragenics faces several risks and challenges, including the inherent uncertainties associated with product development and clinical trials, the need to raise additional capital to fund its operations, and the potential delisting of its common stock from the NYSE American if it is unable to regain compliance with the exchange's continued listing standards.

The company's reliance on the successful development and commercialization of ONP-002 as its lead product candidate also presents a significant risk, as any delays or setbacks in the development of this asset could have a material adverse effect on the company's business, financial condition, and prospects.

Outlook

Oragenics' shift in focus to the development of medical products that treat brain-related illnesses and diseases, particularly its lead candidate ONP-002 for the treatment of concussion, represents a promising opportunity in an area of significant unmet medical need. The company's proprietary intranasal delivery platform and the positive preclinical and early clinical data for ONP-002 suggest that this asset could potentially offer a differentiated and effective treatment option for patients suffering from mild traumatic brain injury.

Conclusion

However, the company's ability to successfully advance the development of ONP-002 and achieve its long-term goals will depend on its ability to secure additional capital and regain compliance with the NYSE American's continued listing standards. Investors should closely monitor the company's progress in these areas, as well as any updates on the ongoing clinical development of ONP-002, to assess the potential of this promising asset and the overall investment thesis for Oragenics.